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Deep Brain Stimulation for the Treatment of Alzheimer's Disease

This study is currently recruiting participants.
Verified May 2013 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Ali Rezai, MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01559220
First received: March 19, 2012
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this clinical study is to investigate the safety and efficacy of deep brain stimulation (DBS)as a treatment option for patients with cognitive, behavioral, and functional disability of Alzheimer's disease.


Condition Intervention
Alzheimer's Disease
 Device: Deep Brain Stimulation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation (DBS) for Treatment of the Cognitive, Behavioral, and Functional Disability of Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Clinical Dementia Rating Scale [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: March 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Label
DBS Implant and stimulation
 Device: Deep Brain Stimulation
Implanted device
Other Name: Deep Brain Stimulation Device

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria

Exclusion Criteria:

  • Has significant neurological disease, other than Alzheimer's disease, e.g., multiple sclerosis, Parkinson's disease and ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or subdural hematomas.
  • Evidence of substance abuse (alcohol or other drug) abuse or dependence during the previous 12 months (DSM-IV Criteria).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559220

Contacts
Contact: Phuong Nguyen 6143666952 phuong.nguyen2@osumc.edu

Locations
United States, Ohio
Wexner Medical Center at the Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Phuong Nguyen     614-366-6952     phuong.nguyen2@osumc.edu    
Principal Investigator: Ali Rezai, MD            
Sponsors and Collaborators
Ali Rezai, MD
Investigators
Principal Investigator: Ali Rezai, MD Ohio State University
  More Information

No publications provided

Responsible Party: Ali Rezai, MD, MD, The Ohio State University
ClinicalTrials.gov Identifier: NCT01559220     History of Changes
Other Study ID Numbers: DBS for AD
Study First Received: March 19, 2012
Last Updated: May 14, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013